Wound closure system

ABSTRACT

A wound closure system includes a device having a first main body and a second main body. Each of the first main body and the second main body has an adhesive backing. The first main body is coupled to the second main body by an adjustable connector. The adjustable connector is permitted to move in a single direction. In the event of an injury, the first and second main bodies are placed on opposite sides of a wound and are then pulled together, thereby sealing the wound.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/895,598, filed on Jun. 8, 2020, which in turn is a continuation ofU.S. patent application Ser. No. 15/976,132, filed on May 10, 2018,which in turn claims the benefit of U.S. Provisional Application No.62/504,020, filed on May 10, 2017. The entire disclosures of the aboveapplications are hereby incorporated herein by reference.

FIELD

The present disclosure relates to a wound closure system and, moreparticularly, to adjustable devices for closing wounds.

BACKGROUND

Closure of wounds such as cuts have traditionally involved stitches orstaples. The technique of properly stitching a wound takes years toperfect. Unfortunately, the average person does not know how to properlystitch a wound in an emergency. Moreover, stitches and staples are notadjustable. If the wound becomes inflamed, the stitches can break andthe wound will rupture.

Furthermore, surgeons confronted with suturing a morbidly obese patientusing retention sutures can subject the patient to complications such asintense pain and pulling at the wound site.

There are a multitude of other devices known for closing wounds. Theseknown devices close and secure a wound, stop or prevent bleeding, andcan minimize the possibility of secondary infections. Such devicesinclude adhesive bandages or butterfly bandages. However, these adhesivebandages are generally suitable for only minor cuts and scrapes, areprone to accidental removal, and are typically not suitable for closingmajor wounds.

Another known wound closure device is described in U.S. Pat. No.9,050,086 to Belson et al. In particular, Belson et al. discloses anapparatus for closing a surgical incision, which comprises a pluralityof closure components for coupling left and right base panels to eachother laterally. A plurality of left and right axial supports arecoupled to the respective base panels. As these panels are pushedcloser, the panels interlock to thereby close a wound.

There is a continuing need for a wound closure system that can be usedwith minimal training for both minor and major wounds. Desirably, thewound closure system can be securely attached to the patient, and israpidly adjustable so as to close wounds quickly and cleanly.

SUMMARY

In concordance with the instant disclosure, a wound closure system thatcan be used with minimal training for both minor and major wounds, andwhich can be securely attached to the patient, and is rapidly adjustableso as to close wounds quickly and cleanly, has been surprisinglydiscovered.

In one embodiment, a wound closure system has a first main body and asecond main body. Each of the first main body and the second main bodyhas an adhesive backing. The first main body is linked to the secondmain body by an adjustable connector. The first and second main bodiesare attached to the adjustable connector at an angled wall. The wall isangled to create a force downward when there is tension between thefirst main body and second main body, which helps keep the main bodiesattached to a patient's body. The adjustable connector includes or isconnected with a closure mechanism that only allows movement of theadjustable connector in one direction. Thus, when the adjustableconnector is pulled, it draws the first and second main body together,militating against any rearward movement. In operation, this iseffective in closing a wound.

Within the scope of the present disclosure, a variety of adjustableconnectors are contemplated. The adjustable connector can be a cord orrope tied in a knot that only allows movement in a single direction. Theadjustable connector can also be a cord or rope that is linked to aunidirectional structure, including a body having an aperture withteeth, the teeth interlocking with the cord when there is any rearwardtension. Further, the adjustable connector can be a bulbed cord linkedto a locking mechanism with interior protrusions or angled surfaces thatonly allows the bulbed cord to move in a single direction. Theadjustable connector can also be a cable tie, or any other mechanismchosen by a skilled artisan that would provide for movement in a singledirection.

In operation, the wound closure system works by peeling away orotherwise removing a protective covering from the adhesive backing, andadhering the first main body and the second main body to a patient onopposite sides of a wound. The first and second main bodies are alsooriented in a manner that ensures the outer surfaces of the angled wallsof the first main body and second main body are facing each other. Oncethe main bodies are affixed to the patient's skin, the user pulls on theadjustable connector, bringing the first main body and second main bodycloser together until the wound is closed. Multiple ones of the woundclosure system can also be used in series for large lacerations,interspersed in series along a length of the wound.

In another embodiment, the inner surface of the angled wall of the firstand second main bodies can face downwards toward the patient's skin.This orientation creates a downward force, helping the main bodies stayattached, while pinching the skin adjacent the wound together.

In a further embodiment, the wound closure system can also containapertures configured to connect with staples on both the first main bodyand second main body. This allows the wound closure system to beattached in situations where adhesive is not suitable or usable.

In another embodiment, the wound closure system can have a first mainbody with fingers and a second main body configured to connect to aplurality of adjustable connectors, referred to as “fingers.” Both mainbodies can be manufactured for use together in a kit, for example,provided in rolls either separately or temporarily connected, and breakoff for easy use. The first and second main bodies possess an adhesivebacking and a removable adhesive covering. The fingers are affixed tothe first main body and selectively couple the first main body to thesecond main body.

In operation, the adhesive covering is removed and the first and secondmain bodies are placed on opposite sides of the wound. The first mainbody is moved toward the second main body by pulling on the fingersuntil the wound is closed. Once the wound is sealed, the fingers of thefirst main body are attached to the second main body. The fingers, forexample, can attach to the second main body using a hook-and-loopfastener material. The fingers allow the cut to breath while militatingagainst wound separation.

Advantageously, the wound closure system can be used as a stand-alonewound closure device, engaged during the entire duration of the woundheal, or used as a temporary hold on a laceration or operative incision.Multiple wound closure devices may also be used together in series toclose lengthy wounds. Moreover, the wound closure system offers surgeonsthe capability of providing a tension adjustment system during operativesuturing or postoperative suturing to assist in resolving complicationscaused by retention suturing in morbidly obese patients.

DESCRIPTION OF THE DRAWINGS

The above, as well as other advantages of the present invention, willbecome clear to those skilled in the art from the following detaileddescription of a preferred embodiment when considered in the light ofthe accompanying drawings in which:

FIG. 1 is a top right perspective view of the wound closure systemaccording to an embodiment of the present disclosure, depicting a singlewound closure device with an adhesive backing;

FIG. 2 is a top left perspective view of the wound closure system shownin FIG. 1;

FIG. 3 is a side elevational view of the wound closure system shown inFIG. 1;

FIG. 4 is a top plan view of the wound closure system shown in FIG. 1;

FIG. 5 is a bottom plan view of the wound closure system shown in FIG.1, with a portion of a removable liner peeled away to show theunderlying adhesive;

FIG. 6 is a top perspective view of the wound closure system shown inFIG. 1, and further shown attached to skin of a patient over an openwound;

FIG. 7 is a top perspective view of the wound closure system shown inFIG. 1, and further shown attached to skin of a patient over a woundclosed by the wound closure device;

FIG. 8 is a top perspective view of a wound closure system according toanother embodiment of the present disclosure including a plurality ofthe wound closure devices and a singular closure line for operating thewound closure devices simultaneously;

FIG. 9A-9B are partial side elevational views showing slip knots for usewith the wound closure system of the present disclosure;

FIGS. 9C-9D are perspective views of closure mechanisms for use withclosure lines of the wound closure system of the present disclosure;

FIG. 9E is a side elevational view showing a beaded closure line for usewith the wound closure system of the present disclosure;

FIG. 10 is a side elevational view of a wound closure system accordingto yet another embodiment of the present, depicting a wound closuredevice with an adhesive backing, and fingers connecting the first andsecond main body; and

FIG. 11 is a top plan view of the wound closure system shown in FIG. 10,and further shown attached to skin of a patient over a wound closed bythe wound closure device.

DETAILED DESCRIPTION

The following detailed description and appended drawings describe andillustrate various exemplary embodiments of the invention. Thedescription and drawings serve to enable one skilled in the art to makeand use the invention and are not intended to limit the scope of theinvention in any manner. In respect of the methods disclosed, the stepspresented are exemplary in nature and, thus, the order of the steps isnot necessary or critical.

In the description, relative terms such as “lower,” “upper,”“horizontal,” “vertical,”, “above,” “below,” “up,” “down,” “top” and“bottom” as well as derivative thereof (e.g., “horizontally,”“downwardly,” “upwardly,” etc.) should be construed to refer to theorientation as then described or as shown in the related drawing. Theserelative terms are for convenience of description and do not requirethat the apparatus be constructed or operated in a particularorientation. Terms concerning attachments, such as “connected,”“connecting,” “coupled,” “linked” and “coupling” are usedinterchangeably and refer to one structure or surface being secured toanother structure or surface, unless expressly described otherwise.

Referring to FIGS. 1-8, a wound closure device 2 according to thepresent disclosure has a first main body 4 and a second main body 6attached by an adjustable connector 8. The wound closure device 2 isused to securely close a wound of a patient, such as a cut orlaceration.

The first main body 4 and the second main body 6 are formed from anyrigid or semi-rigid material suitable for medical use. As non-limitingexamples, the first main body 4 and the second main body 6 may be formedfrom a thermoplastic material such as nylon, polyethylene,polypropylene, and the like. Thermoplastics vulcanizates may also beemployed. Biodegradable materials, and particularly materials that maybe bio-absorbed over time when implanted and after the wound has beensufficiently healed, are also contemplated.

As shown in FIGS. 1-8, each of the first main body 4 and the second mainbody 6 may have a first portion 17 and a second portion 18. As anon-limiting example, the first portion 17 may be formed from a rigid orsemi-rigid thermoplastic material, and the second portion 18 may beformed from a flexible plastic or rubber material, such as a foam rubbermaterial. The first and second portions 18 may be co-molded andphysically secured to one another, or may be formed separately andconnected by adhesives or mechanical fasteners. One of ordinary skill inthe art may select suitable materials and combinations of materials forthe first and second main bodies 4, 6 of the wound closure device 2 ofthe present disclosure, as desired.

The adjustable connector 8 is flexible, to allow for the wound closuredevice 2 to be used on a wide variety of wounds. As nonlimitingexamples, the adjustable connector 8 may be a rope, cord, bulbed cord,or cable tie affixed to a fastener that only allows movement in onedirection, for example, as shown in FIGS. 9A-9E and described furtherhereinbelow. Other suitable types of adjustable connectors 8 may also beemployed within the scope of the disclosure, as desired.

As shown in FIGS. 1-8, the first main body 4 and the second main body 6both have an adhesive backing 20 that attach the main bodies 4, 6 to theskin of a patient 100 (shown in FIGS. 6-7 and 11). The adhesive backing20 may also be selectively covered by a protective covering 21, whichcan be peeled away from the adhesive backing 20 prior to attachment tothe skin of the patient. For example, the adhesive backing may be a typeof Cyanoacrylate glue or a medical adhesive tape from 3M such as 3M 15103M 1522, 3M 1577, 3M 9832, 3M 9877, 3M 9917, 3M 9880, and 3M 1524, orany other adhesive chosen by a skilled artisan.

With reference to FIG. 6, an adhesive can either be applied directly tothe skin, or the protective covering of the adhesive backing 20 may beremoved and the first and second main bodies 4, 6 may be placed on thepatient's skin on opposite sides of the open wound 22. The adjustableconnector 8 is then pulled using a knob, or grasping mechanism 7, in thedirection indicated by the arrow shown in FIG. 7. The main bodies 4, 6,which are adhered to the skin, are subsequently drawn closer together inthe directions indicated by the arrows shown in FIG. 7 until the wound22 is closed. Once the wound 22 is closed, a medical professional canfurther seal the wound using stitches, or a sealant material, asdesired.

Additionally, the first and second main bodies 4, 6 can have apertures(not shown) to accommodate staples. Additionally, or in the alternative,the second portion 18 of the first and second main bodies 4, 6 may alsobe formed from soft and flexible material, such as a foam rubber or thelike, which can be pierced by staples. In such cases, the main bodies 4,6 are placed on opposite sides of a wound and then stapled in place toprovide a better grip.

In emergency situations, a patient can be severely bleeding, which mightprevent adhesive from binding to the skin. In such situations, the useof staples through the main bodies 4, 6 can enable a medical responderto securely affix the main bodies 4, 6 to the skin. Once the main bodies4, 6 are affixed to the skin, the cord 8 is pulled using the knob, orgrasping mechanism 7, and the main bodies 4, 6 are pulled closertogether until the wound 22 is closed. Once the wound 22 is closed, amedical professional can seal the wound 22 using stitches, or a sealantmaterial.

With renewed reference to FIGS. 1-5, the wound closure device 2according to a particular embodiment of the disclosure may have thefirst main body 4 and the second main body 6 attached by the adjustableconnector 8 in the form of a rope or cord. In this embodiment, the cord8 is tied in a knot 30 such as a slip knot or uni-slip knot shown inFIGS. 9A and 9B that only allows the cord 8 to only move in onedirection. The knot 30 allows the cord 8 to tighten between the two mainbodies 4, 6, and prevents the cord from loosening. The first and secondmain bodies 4, 6 both have the adhesive backing 20 that is removedleaving only the adhesive, which allows the main bodies 4, 6 to attachto the skin.

In this embodiment, the first main body 4 further has an angled housing12. The angled housing 12 may be defined by an angled wall 10 and adownwardly-extending back portion 11 that results in a substantiallytriangular- or tent-shaped body that is used to house the knot 30. Thesecond main body 6 also has an angled wall 10. The angled walls 10 ofthe first and second main bodies 4, 6 serve to direct the force createdby tension between the two main bodies downward as the adjustableconnector 8 is pulled, thereby providing more grip and surface tensionon the skin.

Furthermore, each of the angled walls 10 of the first and second mainbody 4, 6 contains at least one aperture 14 through which the adjustableconnector 8 is disposed. The angle wall of the first main body 4 mayhave a single aperture 14, which is sized appropriately to allow theadjustable connector 8 to be disposed therethrough while doubled. Theangled wall 10 of the second main body 6 may have two apertures 14, forexample, which allows the adjustable connector 8 to be looped throughthe two apertures 14 of the angled wall of 10 of the second main body 6.This looping of the adjustable connector through both apertures 14 ofthe second main body 6 secures the adjustable connector 8 to the secondmain body 6.

The downwardly-extending back portion 11 of the angled housing 12 of thefirst main body 4 may also have a single aperture 16 through which theadjustable connector 8 is likewise disposed. It should be appreciatedthat only the portion of the adjustable connector 8 that is configuredto be gripped and pulled by the user may be disposed through the singleaperture 16 of the back portion 11.

Importantly, the single aperture 16 has a diameter that is less than adiameter of the knot 30 contained within the angled housing 12, so thatthe knot 30 (or a corresponding closure mechanism, described furtherbelow) cannot be pulled through the single aperture 16 when theadjustable connector 8 is pulled. In operation, as the adjustableconnector 8 is manually pulled, the knot 30 will abut an inner surfaceof the angled housing 12. This allows the first and second bodies 4, 6,to be irreversibly drawn toward each other as the knot 30 is tightenedby the pulling of the adjustable connector 8.

It should be appreciated that the knot 30 shown in FIGS. 1-5 and 9A-9Bmay be replaced with other types of closure mechanisms that permit theunidirectional travel of the adjustable connector 8 therethrough, andwhich prevent the cord from retreating therethrough. For example, asshown in FIGS. 9C-9D a closure mechanism 34 may include a boy having acentral aperture and a plurality of angled teeth 35. The orientation ofthe teeth 35 ensure that the adjustable connector 8, such as the cord orclosure line, can only be pulled through the central aperture of theclosure mechanism 34 in a single direction. When the cord 8 experiencesrearward tension, the teeth 35 interlock with the cord 8 stopping itfrom moving backward. In operation, as the adjustable connector 8 ismanually pulled, the closure mechanism 34 will abut the inner surface ofthe angled housing 12. This allows the first and second bodies 4, 6, tobe irreversibly drawn toward each other as the adjustable connector 8 ispulled through the central aperture of the closure mechanism 34 and thesingle aperture 16 of the angled housing 12.

In yet another example, the adjustable connector 8 and knot 30 may bereplaced with a bulbed cord 9 and locking mechanism 27 as shown in FIG.9E. The bulbed cord 9 may be affixed to the angled wall 10 on the secondmain body 6. The angled wall 10 or downwardly-extending back portion 11on the first main body 4 may be integral with or connected to theone-way locking mechanism 27 that allows the cord to only move in onedirection. For example, the locking mechanism 27 may have a set ofdiagonal flexible protrusions (now shown) that allow the individualbulbs to be pulled forward, but which stop the individual bulbs frommoving backwards through the locking mechanism 27. In operation, whenthe user wishes to apply the wound closure device 2, the adhesivebacking 20 is removed and the main bodies 4, 6 are placed adjacent toeach other on opposite sides of the wound 22. The bulbed cord 9 ispulled using a knob, or grasping mechanism 7, which results in the mainbodies 4, 6 pulling the skin together until the wound 22 is closed. Thenthe responder can then use stitches, or sealant to bind the wound 22shut.

Although the wound closure device 2 is described hereinabove withrespect to a single device used to close the wound 22, it should beappreciated that the wound closure device 2 can be used in a series toclose larger lacerations 22, as shown in FIG. 38. Multiple wound closuresystems 2 are placed with their main bodies 4, 6 on opposite sides ofthe laceration 22. The adjustable connectors 8 of each of the woundclosure systems 2 can be connected to a single pull line 40, forexample, to facilitate a simultaneous operation of all of the woundclosure along the length of the wound 22. The wound closure systems 2are then operated to close the laceration 22, as shown in FIG. 8.

FIGS. 9A and 9B illustrate a series of steps to create suitable knot 30for use with the wound closure device 2 of the disclosure. These knots30 allow the adjustable connector 8 to move in one direction, whilepreventing it from moving in the opposite direction. FIG. 9A is astepwise instruction on how to tie a slip knot, while FIG. 9B is astepwise instruction on how to tie a uni-slip knot. Other unidirectionalknots are also contemplated and within the scope of the presentdisclosure.

FIGS. 9C and 9D show the closure mechanisms 34 with the teeth 35 thatenables adjustable connector 8 to pass one way, but when the adjustableconnector 8 is pulled in the opposite direction the teeth 35 interlockwith the adjustable connector 8 and secure it in place.

FIG. 9E illustrates an additional embodiment of the wound closure device2, which has the first main body 4 and the second main body 6 attachedby the bulbed cord 9 that allows the main bodies 4, 6 to move closertogether while preventing backward motion.

FIGS. 10 and 11 illustrate a further embodiment of the wound closuredevice 2′ according to the present disclosure. Like or related structureto that shown in FIGS. 1-9E is identified in FIGS. 10 and 11 with thesame number and prime symbol (′) for purpose of clarity.

As shown in FIG. 10, the wound closure device 2′ has a first main body4′ and a second main body 4′. The first main body 4′ has a plurality ofadjustable connectors or fingers 8′ that extend outwardly from the firstmain body 4′ and which are configured to releasably connect or bind withthe second main body 6′. Together, the first and second main bodies 4′,6′ can be used to close a wound 22′, for example, as shown in FIG. 11.

Each of the first and main bodies 4′, 6′ can be manufactured as aunitary strip of material, rolled into a compact form for distributionand storage, and with individual pieces to be broken off, cut, or tornfrom the roll for end use. The first and second main bodies 4′, 6′ havean adhesive backing 20′ and a removable protective covering (not shown).In operation, the protective covering is removed and the first andsecond main bodies 4′, 6′ are placed on opposite sides of the wound 22′,so that the adhesive backing 20′ holds the first and second main bodies4′, 6′ securely in place on the patient's skin 100′.

The first main body 4′ is then moved toward the second main body 6′, forexample, by pulling on at least one of the fingers 8′, until the wound22′ is closed. Once the wound 22′ is sealed, the fingers 8′ of the firstmain body 4′ are attached to the second main body 6′.

In a particular example, the fingers 8′ can attach to the second mainbody 6′ through use of hook-and-loop fastener 42′. The hook-and-loopfastener 42′ may be disposed on an underside of the fingers 8′ of thefirst main body 4′ and a topside of the second main body 6′. The matingof the hook-and-loop fastener material 42′ allows the first main body 4′to be selectively, securely, and reversibly attached to the second mainbody 6′. The fingers 8′ connected by hook-and-loop fastener materialalso allows the wound 22′ to breath while militating against woundseparation.

Advantageously, the wound closure device 2, 2′ of the present disclosurecan be used with minimal training to be securely attached to thepatient. The wound closure device 2, 2′ is also adjustable, can berapidly and cleanly applied, and can be used with a wide variety ofwound types.

While certain representative embodiments and details have been shown forpurposes of illustrating the invention, it will be apparent to thoseskilled in the art that various changes may be made without departingfrom the scope of the disclosure, which is further described in thefollowing appended claims.

What is claimed is:
 1. A wound closure device comprising: a first mainbody and a second main body, the first main body spaced apart from thesecond main body, and each of the first main body and the second mainbody having an adhesive backing; and an adjustable connector couplingthe first main body to the second main body, the first main body havinga first angled wall and the second main body having a second angledwall, wherein the first angled wall and the second angled wall areoriented so that a movement of the first main body toward the secondmain body by the adjustable connector in operation results in a downwardforce being applied to the first main body and the second main body. 2.The wound closure device of claim 1, wherein an outer surface of thefirst angled wall of the first main body faces an outer surface of thesecond angled wall of the second main body.
 3. The wound closure deviceof claim 1, wherein the second angled wall of the second main bodycontains two apertures configured to receive the adjustable connector.4. The wound closure device of claim 3, wherein the first angled wall ofthe first main body includes a single aperture configured to receive theadjustable connector.
 5. The wound closure device of claim 4, furthercomprising a downwardly-extending back portion that depends from thefirst angled wall of the first main body.
 6. The wound closure device ofclaim 5, wherein the back portion contains a second aperture configuredto receive the adjustable connector.
 7. The wound closure device ofclaim 1, further comprising at least one of a knob and a graspingmechanism disposed on the adjustable connector.
 8. The wound closuredevice of claim 1, wherein the first main body and second main body areconfigured to receive staples.
 9. The wound closure device of claim 1,wherein each of the first main body and the second main body has a firstportion and a second portion, the first portion secured to the secondportion.
 10. The wound closure device of claim 9, wherein the firstportion is formed from a rigid or semi-rigid thermoplastic material, andthe second portion is formed from a flexible plastic or rubber material.11. The wound closure device of claim 10, wherein the second portion isformed from foam rubber.
 12. A wound closure system comprising aplurality of wound closure devices, wherein each of the wound closuredevices comprises: a first main body and a second main body, the firstmain body spaced apart from the second main body, and each of the firstmain body and the second main body having an adhesive backing; and anadjustable connector coupling the first main body to the second mainbody, the first main body having a first angled wall and the second mainbody having a second angled wall, wherein the first angled wall and thesecond angled wall are oriented so that a movement of the first mainbody toward the second main body by the adjustable connector inoperation results in a downward force being applied to the first mainbody and the second main body.
 13. The wound closure system of claim 12,further comprising a single closure or pull line connected to each ofthe adjustable connectors for operating the wound closure devicessimultaneously.
 14. The wound closure system of claim 12, furthercomprising at least one of a knob and a grasping mechanism disposed onthe adjustable connector.
 15. A kit for a wound closure devicecomprising: a first main body having a first adhesive backing and afirst angled wall; a second main body having a second adhesive backingand a second angled wall; and an adjustable connector configured tocouple the first main body to the second main body, with the first mainbody spaced apart from the second main body, and the first main bodyhaving a first angled wall and the second main body having a secondangled wall, wherein the first angled wall and the second angled wallare oriented so that a movement of the first main body toward the secondmain body by the adjustable connector in operation results in a downwardforce being applied to the first main body and the second main body. 16.The wound closure kit of claim 15, further comprising a unidirectionalstructure configured to be disposed on the first main body.
 17. Thewound closure kit of claim 15, further comprising a plurality of thewound closure devices configured to be arranged along a length of awound, wherein in the kit further comprises a single closure or pullline configured to be connected to each of the adjustable connectors ofthe plurality of the wound closure devices.
 18. The wound closure kit ofclaim 15, further comprising at least one of a knob and a graspingmechanism configured to be disposed on the adjustable connector.